褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号520023-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数10000
标示量(mg)1供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 9.856577165673655196564065669656540.14
2 9.896557865643656100.08
单位质量响应值RSD%判断
6665.386633.970.34数据可信
供试品溶液-2025040921批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min170431-7043195.23094.960.8595.2394.960.85
270068-7006894.73994.74
370054-7005494.72094.72
471128-7112896.17296.17
570409-7040995.20095.20
669318-6931893.72593.73
10min170469-7046995.28195.911.1795.4496.071.17
270134-7013494.82894.99
370251-7025194.98795.14
472160-7216097.56897.73
571699-7169996.94497.10
670912-7091295.88096.04
15min170530-7053095.36495.751.1095.6896.071.10
270165-7016594.87095.19
370200-7020094.91895.23
472074-7207497.45197.77
571470-7147096.63596.96
670466-7046695.27795.59
20min170384-7038495.16695.861.1795.6496.341.17
270080-7008094.75595.23
370646-7064695.52196.00
472121-7212197.51598.00
571736-7173696.99497.48
670406-7040695.19695.67
30min170063-7006394.73295.661.3095.3796.301.29
269705-6970594.24894.88
370638-7063895.51096.14
471946-7194697.27897.93
571763-7176397.03197.67
670375-7037595.15495.79
极限170277-7027795.02295.401.5295.8196.201.51
269412-6941293.85294.64
370365-7036595.14195.93
472186-7218697.60398.41
571458-7145896.61997.42
669663-6966394.19294.98
褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号520023-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数10000
标示量(mg)1供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 9.856556965605656016551465679655940.10
2 9.896572565399655620.36
单位质量响应值RSD%判断
6659.296629.120.33数据可信
供试品溶液-2025040921批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min169712-6971294.33595.111.1694.3495.111.16
270166-7016694.95094.95
370137-7013794.91194.91
469273-6927393.74193.74
570895-7089595.93695.94
671533-7153396.80096.80
10min169517-6951794.07295.681.1694.2395.841.16
270747-7074795.73695.89
370653-7065395.60995.77
470160-7016094.94295.10
571837-7183797.21197.37
671312-7131296.50196.66
15min169399-6939993.91295.501.2694.2395.821.26
270525-7052595.43695.75
370163-7016394.94695.26
470128-7012894.89895.21
571612-7161296.90797.23
671616-7161696.91297.23
20min169567-6956794.13995.560.9994.6196.040.98
270769-7076995.76696.24
370214-7021495.01595.49
470467-7046795.35795.83
571219-7121996.37596.86
671467-7146796.71097.19
30min169616-6961694.20695.531.4194.8396.161.40
270224-7022495.02895.66
370101-7010194.86295.50
470021-7002194.75495.39
571393-7139396.61097.25
672205-7220597.70998.35
极限170136-7013694.90995.370.9295.6996.170.92
270193-7019394.98695.78
369855-6985594.52995.32
470179-7017994.96795.76
570931-7093195.98596.79
671574-7157496.85597.66
褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号520023-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数10000
标示量(mg)1供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 9.856561365610656706560465545656080.07
2 9.896529365499653960.23
单位质量响应值RSD%判断
6660.716612.340.52数据可信
供试品溶液-2025041021批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min171209-7120996.47495.151.6796.4795.161.66
268076-6807692.22992.23
369916-6991694.72294.72
471192-7119296.45096.45
570606-7060695.65795.66
670414-7041495.39695.40
10min171602-7160297.00696.541.5997.1796.701.59
269397-6939794.01994.17
370883-7088396.03296.19
472843-7284398.68798.85
571592-7159296.99297.15
671227-7122796.49896.66
15min171078-7107896.29696.811.9196.6297.121.90
269928-6992894.73895.05
371066-7106696.28096.60
473981-73981100.229100.55
571658-7165897.08297.40
671017-7101796.21396.53
20min171305-7130596.60496.321.5197.0996.801.51
269557-6955794.23594.70
371029-7102996.23096.71
472780-7278098.60299.09
571420-7142096.75997.24
670490-7049095.49995.98
30min171264-7126496.54896.401.6597.1997.041.65
269631-6963194.33694.96
370836-7083695.96896.61
473197-7319799.16799.82
571301-7130196.59897.24
670703-7070395.78896.43
极限171607-7160797.01396.921.6897.8297.721.68
271028-7102896.22897.01
370959-7095996.13596.93
473832-73832100.027100.85
571387-7138796.71597.52
670405-7040595.38496.18
褪黑素颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号520023-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数10000
标示量(mg)1供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 9.856554465393655046546965248654320.18
2 9.896565165731656910.09
单位质量响应值RSD%判断
6642.846642.160.01数据可信
供试品溶液-2025041021批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min169257-6925793.74395.221.9593.7495.221.95
270429-7042995.33095.33
368402-6840292.58692.59
472290-7229097.84997.85
571046-7104696.16596.16
670653-7065395.63395.63
10min170075-7007594.85096.531.3895.0196.691.38
271880-7188097.29497.45
370369-7036995.24895.40
472105-7210597.59897.76
572476-7247698.10098.26
671012-7101296.11996.28
15min169986-6998694.73096.501.7195.0496.821.71
271415-7141596.66496.99
369752-6975294.41394.73
472669-7266998.36298.69
572468-7246898.08998.41
671472-7147296.74197.06
20min170053-7005394.82196.331.4295.2996.811.42
271392-7139296.63397.12
369995-6999594.74295.21
472574-7257498.23398.72
571831-7183197.22797.71
671150-7115096.30696.79
30min170144-7014494.94496.181.3295.5796.821.32
271323-7132396.54097.18
369842-6984294.53595.16
472385-7238597.97798.63
571534-7153496.82597.47
671126-7112696.27396.91
极限170202-7020295.02296.131.3395.8196.931.33
270832-7083295.87596.68
369845-6984594.53995.32
472421-7242198.02698.84
571628-7162896.95397.76
671193-7119396.36497.17
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